Spinal Morphine for Postoperative Analgesia in Urology
|ClinicalTrials.gov Identifier: NCT03675646|
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Morphine||Phase 4|
Patients elicited for open prostatectomy or open nephrectomy were randomly divided in 2 groups. Group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces. Control group (C) were given no intervention. Placebo intrathecal injection in C was not used because of ethical reason. Standard general anaesthesia was used in both groups. After surgery all patients were transferred to urology ICU and were given standard analgesic regimen according to level of pain measured by numeric rating scale (NRS) 0 - 10: NRS > 3 metamizol 1 g IV every 6 h., max. 4 g/24 h., NRS > 3 paracetamol 1g IV every 6 h., max. 4 g/24 h., NRS > 3 lasting 30 min. after administration of previous ones diclofenac 75 mg IM á 12 h., max. 150 mg/24 h., NRS > 4 morphine 10 mg SC á 6 h. Personnel of ICU was blinded to the analgesic method used.
Noticed parameters: pain intensity (NRS), time to NRS ≥ 4, time to the first morphine request, side effects (respiratory rate <8, SpO2<90 %, nausea, vomiting, naloxone administration for SpO2<88 %, itching).
Standard statistical analysis was used, p value < 0.05 was considered significant.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patient elicited for open prostatectomy or open nephrectomy were given intrathecal morphine in normal saline before induction to general anaesthesia (GA) or GA only. After surgery, time to the first opioid request, total opioid consumption during first 24 hours and 48 hours after surgery and opioid side effects were noticed.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Only ICU personnel was blinded to the method used|
|Official Title:||Comparison of Spinal Morphine With Systemic Analgesia After Urologic Surgery|
|Actual Study Start Date :||March 5, 2016|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||July 10, 2017|
Experimental: Morphine group M
Experimental group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces.
Intrathecal injection of 250 mcg preservative-free morphine before surgery
Other Name: No other names
No Intervention: Control group C
- Duration of analgesia [ Time Frame: 48 hours ]Time to the first morphine request during the first two days of ICU stay after surgery (in hours) and total morphine consumption during the first two days of ICU stay (in mg)
- Morphine side effects [ Time Frame: 48 hours ]respiratory rate <8, SpO2<90 %, nausea, vomiting, naloxone administration for SpO2<88 %, itching
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675646
|University Hospital Kralovske Vinohrady|
|Praha, Czechia, 100 00|
|Principal Investigator:||Jiri Malek, M.D.||3rd Medical Faculty, Charles University|